Successful Phase III Trials and FDA Designations
Completed pivotal Phase III trial for pediatric steroid-refractory acute graft versus host disease, achieving primary endpoint. FDA granted regenerative medicine advanced therapeutic (RMAT) designation for heart failure and inflammatory back pain treatments.
Intellectual Property and Manufacturing Advancements
Mesoblast holds over 1,100 patents across major jurisdictions. Achieved scalable manufacturing processes with innovations like 3D bioreactors, inspected and approved by FDA at Lonza facility.
Financial Improvements
Cash reserves at USD 77.6 million with a 25% reduction in cash burn for operating activities in the last quarter compared to the previous year. Loss after tax reduced by 21%.
Pediatric Rare Disease and Orphan Drug Designations
Revascor received rare pediatric disease and orphan drug designations from FDA for hypoplastic left heart syndrome, potentially eligible for a priority review voucher.